MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿; MESH, SURGICAL, POLYMERIC

Model Number 482812

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994); Scarring (2061); Tissue Damage (2104); Discharge (2225); Distress (2329); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vault prolapse, large cystocele and stress urinary incontinence.It was reported that after implant, the patient experienced blood loss, third degree cystocele, second degree rectocele (prolapse), second to third degree uterine prolapse, endometrial lesion, extensive scarring under the bladder (scarring), pelvic organ prolapse pelvic floor prolapse, continued urinary incontinence, continued/increased stress urinary incontinence, myomas x 2, hypermobile urethra, very thickened anterior vaginal wall due to the graft, uterine polyps, continuous pain, discomfort, drainage, mental and physical stress, vaginal vault damage, recurrence, infection, unspecified urinary problems, unspecified bowel problems, as well as unspecified neuromuscular problems.The device had been used with mentor ob/tape 93-4000 (lot# 040702e).Post-operative patient treatment included additional surgical interventions.

• Brand Name: MESH TSL - PELVICOL¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8768489
• MDR Text Key: 150389102
• Report Number: 9617613-2019-00117
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2006
• Device Model Number: 482812
• Device Catalogue Number: 482812
• Device Lot Number: 04B23-9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 113